A Guide on CDSCO Guidelines for Medical Devices   in India

The Medical Devices Rules, 2017, has laid down the standards for manufacturing and importing medical devices in India. Devices exported from foreign countries such as France, China, USA, Japan, Canada, KSA, European Union, etc., must obtain valid approval and quality clearance certificates under their respective laws and regulations. The Medical Devices Rules as well as the CDSCO Guidelines for medical devices mandate that the devices imported into India must undergo requisite clinical investigations and have to procure an intended use certificate. The CDSCO guidelines for medical devices ensure that the devices manufactured or imported in India comply with internationally accepted safety and quality control standards.

Types of Medical Devices in India

Medical Devices manufactured and sold in India are classified into five different categories –

1. Diagnostic and Imaging devices – X-ray, MRI, etc.
2. Injectables and consumables – Syringe, Needles, Drips etc
3. Dental Products – Braces, tooth caps, crowns, dentures
4. Prosthetics – Crutches, artificial implants, arms, knee implants, artificial joints
5. Patient Aids – hearing aids, pacemakers,eye lenses, etc.

Classification of Devices based on risk factor

Based on the risk involved in their usage and handling, the four categories of devices are divided into four categories –

Category A – These devices signify Low risk factor

Category B – These devices carry low to moderate risk factor

Category C –These devices fall in the moderate to high-risk category

Category D – These devices fall in High – risk category

A new circular issued on November 1, 2017, states that even the companion parts of medical equipment or their auxiliary peripherals must be categorized.

Bodies Regulating CDSCO Guidelines for Medical Devices

The Central Government has entrusted the regulation of CDSCO medical devices to the Central Drug Standard Control Organization and the State Drug Standard Control Organization, which administers the same within states and union territories. The restive central and state authorities have created separate licensing authorities to oversee the licensing procedure of these domains. They are –

The Central Licensing Authority (CLA) will have direct control over Class C and D medical device production. It will oversee and manage the importation of all medical equipment belonging to the A, B, C, and D classes. All new medical devices and in-vitro diagnostic device licenses will be approved after a clinical efficacy assessment and clearance test. It will supervise clinical studies and grant approvals for any medical equipment utilized in research.

The State Licensing Authority (SLA) will oversee the production of Class A and B medical devices. It will supervise the distribution and sale of all four classes’ worth of equipment.

CDSCO Regulatory guidelines for specific entities

Based on the commercial activity undertaken by the license-holder of a CDSCO Authorizing, i.e. manufacturer, importer, distributor, etc, The Government and CDSCO have prescribed certain forms and disclosures that need to be submitted with the regulatory authority before commencing operations. They are –

For Manufacturers –

• An application must be completed in order to obtain a license to produce devices in Classes A and B for distribution or sale in Form MD -3.
• An application that must be completed in order to obtain a loan license to produce devices in Classes A and B for sale or distribution in Form MD – 4.
• An application in Form MD-5 will grant the right to manufacture Class A and B medical devices on the individual’s own manufacturing unit or premises.
• Form MD -6 is used to obtain a license to manufacture medical devices of classes A and B on the property of other manufacturers.
•  An application must be completed in order to obtain a license to produce devices in Classes C and D for distribution or sale in Form MD -7.
• An application in Form MD – 8 must be completed to get a borrowing license to produce Class C and D devices for distribution or sale.
• Form MD-9 is used to grant permission to manufacture Class C and D medical devices on the manufacturers’ premises.
• Form MD-10 is the form used to grant licenses to manufacture Class C and D medical devices on the premises of any other manufacturers.
• Form MD-12 and Form MD-13 are required to be filed to obtain a clinical test license.
• In order to conduct clinical investigations of a new medical device falling under Category C and D, an application in Form MD-23 is required to be filed.

For Importers-

• Similarly, for manufacturers, in order to conduct clinical investigations of a new medical device falling under Category C and D, an application in Form MD-23 is required to be filed.
• To obtain a license to import medical devices for sale or distribution through an authorized agent who already holds a license for the manufacture, sale, and distribution of medical devices or a wholesale license for the same, an online application must be submitted to the Central Licensing Authority (CLA) in Form MD -14.
• If the application complies with all requirements, an import license will be issued in Form MD-15.
• Importers of medical devices are required to obtain a test license first in order to establish the availability of the device. The device licenses can be procured in Form MD-17 and MD-16.
• A late payment fee equal to 2% of the licensing cost each month will be applicable to the license holder if they fail to pay the required amount by the deadline. Alternatively, they may choose to make a partial payment within 180 days. The license will be considered cancelled if the license holder continues to neglect to pay the late charge.

The process to obtain a license for CDSCO medical devices

Clinical testing of the Medical Device

In order to comply with the CDSCO Guidelines for medical devices, our specialists will first assess the class of your medical device, in vitro diagnostics device, patient aid, or consumables, along with the applicable form that needs to be filled out.

Filing of Application and necessary documentation

Prior to filling out the appropriate Forms and submitting requisite documentation to comply with the CDSCO Regulatory guidelines

for medical devices, our specialists will assess the class and type of your medical device, in vitro diagnostics devices, patient aids, or consumables.

Grant of CDSCO License

Upon satisfactory verification of the required documents and data by the relevant licensing body, the CDSCO registration for cosmetics, in vitro diagnostics, and medical devices is obtained.

LICENSE VALIDITY

If the CDSCO License fee is paid in accordance with the Second Schedule of the Medical Devices Rules, 2017, before the license’s expiration date of five years, a license, loan license issued under Form MD-5, MD-6, Form MD-9, MD-10, or import license issued under Form MD-15 will remain valid indefinitely, expect suspension or cancellation by the State or Central Licensing Authorities under any exceptional circumstances.

The CDSCO medical devices license holder will be subject to an additional late payment fee equal to 2% of the licensing fee per month or pay a portion of the license fee if they fail to pay the requisite amount by the deadline.

Conclusion

Medical apparatuses and equipment used in hospitals, dispensaries, and clinics in India have to be manufactured and imported as per CDSCO Guidelines for Medical Devices. These medical devices are manufactured as per the CDSCO Regulations and any deviations from the guidelines can lead to serious implications,concerning the health and well-being of the patients and consumers of these medical devices and paraphernalia.

You willfind whatever you need with respect to having your medical business registered at Corpbiz. Be it compliance with CDSCO guidelines for Medical Devices, or statutory clearance CDSCO medical devices, Coprbiz’s specialized advisory and licensing services can help you achieve your goal of setting -up a Medical Devices manufacturing or Distribution business in India.

Frequently Asked Questions (FAQs)

Read Our Article: CDSCO Guidelines For Medical Device Import